1000 Participants Needed

Multimodal Therapy for Brain AVM

(TOBAS Trial)

Recruiting at 30 trial locations
JR
TD
Daniel Roy, MD profile photo
Overseen ByDaniel Roy, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Multimodal Therapy for Brain AVM?

Research shows that combining different treatments like surgery, embolization (blocking blood vessels), and radiosurgery (targeted radiation) can be effective for treating brain arteriovenous malformations (AVMs). Radiosurgery alone has been successful in treating small AVMs, with significant improvement in many patients and fewer complications compared to traditional surgery.12345

Is multimodal therapy for brain AVM generally safe for humans?

Research shows that treatments like proton beam therapy and Gamma Knife Radiosurgery for brain arteriovenous malformations (AVMs) are generally safe, with low risk of injury to normal brain tissue. However, there can be adverse effects, especially with larger AVMs or inadequate doses.678910

How is the multimodal therapy for brain AVM different from other treatments?

The multimodal therapy for brain AVM is unique because it combines neurosurgery, radiation therapy, and endovascular techniques to treat the condition. This approach allows for a more comprehensive treatment by reducing the size of the AVM, preparing it for surgical removal, and addressing associated risks, which is not typically achieved with a single treatment method.411121314

What is the purpose of this trial?

The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management.The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%).As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.

Research Team

DR

Daniel Roy, MD

Principal Investigator

CHUM-Montreal

Eligibility Criteria

The TOBAS study is for patients with brain arteriovenous malformations (AVMs), which are tangles of abnormal blood vessels connecting arteries and veins in the brain. It's open to all such patients, except those needing urgent surgery due to bleeding effects from AVM.

Inclusion Criteria

I have a brain AVM.

Exclusion Criteria

I had surgery for a bleeding in my brain that needed immediate attention.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive interventional therapy (neurosurgery, radiosurgery, or endovascular procedures) or conservative management

Varies based on treatment modality

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on neurological events and status

10 years

Nested Trial on Embolization

Pre-surgical or pre-radiosurgery embolization of cerebral AVMs to decrease treatment failures

Varies based on treatment modality

Treatment Details

Interventions

  • Embolization
  • Neurosurgery
  • Radiation therapy
Trial Overview This trial explores whether medical management or interventional therapies like embolization, neurosurgery, or radiation—alone or combined—can significantly reduce death/stroke risks in AVM patients over a decade. It also examines if pre-treatment embolization can enhance the success of other treatments.
Participant Groups
2Treatment groups
Active Control
Group I: Interventional therapyActive Control3 Interventions
Interventional therapies include: neurosurgery (surgical resection when the lesion is considered by a multidisciplinary team to be safely 'operable'); radiation therapy (when the AVM is smaller than 3 cm, and considered to not be safely 'operable'); radiosurgery, alone or in combination, with or without endovascular procedure; curative embolization (when the lesion is considered curable by embolization). Patients with AVMs that the multidisciplinary team judges could potentially benefit from endovascular treatment prior to surgical resection or radiation therapy will then also be pre-randomly allocated to embolization or to no embolization.
Group II: Conservative management (medical management)Active Control1 Intervention
The conservative, or medical management arm, involves pharmacological therapy as deemed appropriate for medical symptoms as determined by the treating investigator. Should patients in the conservative management arm develop hemorrhage or infarction related to their AVM, they then potentially become candidates for interventional therapy.

Neurosurgery is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Neurosurgery for:
  • Brain Arteriovenous Malformations (AVMs)
  • Ruptured AVMs
  • Unruptured AVMs
🇺🇸
Approved in United States as Neurosurgery for:
  • Brain Arteriovenous Malformations (AVMs)
  • Ruptured AVMs
  • Unruptured AVMs
🇨🇦
Approved in Canada as Neurosurgery for:
  • Brain Arteriovenous Malformations (AVMs)
  • Ruptured AVMs
  • Unruptured AVMs

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Centre Hospitalier Régional et Universitaire de Brest

Collaborator

Trials
9
Recruited
21,100+

Findings from Research

In a study of 115 patients with cerebral arteriovenous malformations (AVMs), a multidisciplinary approach combining surgery, embolization, and gamma radiosurgery resulted in a treatment success rate of 76.4%, with 41.7% achieving complete cure.
The treatment methods had a low complication rate, with only 4.8% experiencing permanent morbidity and 1.2% mortality, indicating that this combined approach is both effective and relatively safe.
[Multidisciplinary treatment of cerebral arteriovenous malformations: preliminary results in 115 consecutive patients].van Rooij, WJ., Sluzewski, M., Wijnalda, D., et al.[2016]
Radiosurgery effectively treats small intracranial tumors and arteriovenous malformations (AVMs) using precise radiation delivery, with applications for both malignant tumors (like brain metastases and gliomas) and benign tumors (such as meningiomas and acoustic neuromas).
Most patients experience clinical improvement with radiosurgery, and it generally results in less morbidity compared to traditional surgical resection, despite the potential for complications.
Clinical uses of radiosurgery.Chang, SD., Adler, JR., Hancock, SL.[2006]
In a study of 24 patients with large brain arteriovenous malformations (AVMs), the combination of particulate embolization and stereotactic radiosurgery resulted in a 50% complete obliteration rate, which is comparable to the 58% rate seen in smaller AVMs treated with radiosurgery alone.
While some recanalization of embolized AVM segments occurred in 12% of patients, the overall long-term occlusion rates were high, and the combined treatment approach was found to be more effective than using radiosurgery alone for large AVMs.
The efficacy of particulate embolization combined with stereotactic radiosurgery for treatment of large arteriovenous malformations of the brain.Mathis, JA., Barr, JD., Horton, JA., et al.[2021]

References

[Multidisciplinary treatment of cerebral arteriovenous malformations: preliminary results in 115 consecutive patients]. [2016]
Clinical uses of radiosurgery. [2006]
The efficacy of particulate embolization combined with stereotactic radiosurgery for treatment of large arteriovenous malformations of the brain. [2021]
Determinants of staged endovascular and surgical treatment outcome of brain arteriovenous malformations. [2022]
Stereotactic radiation therapy and radiosurgery. [2018]
Quantitative Analysis of Parenchymal Effects and Flow of Large Arteriovenous Malformations Managed With Stereotactic Radiosurgery. [2023]
Stereotactic Bragg peak proton beam radiosurgery for cerebral arteriovenous malformations. [2004]
Fractionated, stereotactic proton beam treatment of cerebral arteriovenous malformations. [2019]
Stereotactic radiosurgery of cerebral arteriovenous malformations with a multileaf collimator and a single isocenter. [2019]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Feasibility of Gamma Knife Radiosurgery for Brain Arteriovenous Malformations According to Nidus Type. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Comparative effectiveness of treatments for cerebral arteriovenous malformations: trends in nationwide outcomes from 2000 to 2009. [2022]
Multimodality Management of Cerebral Arteriovenous Malformations with Special Reference to AVM-Related Hemorrhages During Ongoing Staged Treatment. [2017]
Intraoperative angiography reloaded: a new hybrid operating theater for combined endovascular and surgical treatment of cerebral arteriovenous malformations: a pilot study on 25 patients. [2013]
14.United Statespubmed.ncbi.nlm.nih.gov
Endovascular treatment of cerebral arteriovenous malformations. [2013]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security